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Supplier Quality Questionnaire

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A. General Information on Company, Product and Quality


Management
1. Company Information
1.1 Company Address Information

Name of company:

Address:

Postcode:

Country:

Telephone number:

Fax number:

Web address:

1.2 Is the address listed above the only site for production? Yes No If NO, please provide details below:

Name of company(s):

Address:

Postcode:

Telephone number:

Fax number:

1.3 Is your company a subsidiary? Yes No If Yes, please provide details below:

Name of company:

Address:

Postcode:

Telephone number:

Fax number:
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1.4 Contact Information (Please provide details of an available contact)

Name:

Position:

Telephone number:
Fax number:
Email address:
1.5 Site Personnel Information

1.5.1 Approximate total number of employees at facility of interest:

1.5.2 Approximate number of employees in the Quality Unit (Quallity


Assurance/Quality Control)

1.5.3 Approximate number of employees in Production/Operations Unit

1.5.4 If available, please enclose a copy of your Organisational chart


Enclosed Ref: N/A
indicating key personnel.

1.5.5 If available, could you please supply copies of any sales information
Enclosed Ref: N/A
for the products listed on the front of this form?

1.5.6 Does your factory operate in a shift system? Yes No

How many?

How many days a week?

1.6 Company structure

1.6.1 What is the legal ownership structure of your company?

1.6.2 Please give a brief structure-diagram Ref:

1.6.3 Do you expect a change of the legal status and/or ownership of your company in the
Yes No
near future?

1.6.4 Do you have an annual report available? Yes No

If yes, please enclose the annual report Ref:


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2. Product Information
2.3 Origin of the main ingredients Comments

2.3.1 Synthetic Yes No N/A

2.3.2 Fermentation Yes No N/A

2.3.3 Vegetable Yes No N/A

2.3.4 Mineral Yes No N/A

2.3.5 Animal (if YES, please complete section B as well) Yes No N/A

2.3.5 Bovine (or by-products) Yes No N/A

2.3.5 Porcine (or by-products) Yes No N/A

2.3.5 Poultry (or by-products) Yes No N/A

2.3.5 Fish (or by-products) Yes No N/A

2.3.5 Human (or by-products) Yes No N/A

2.4 Origin of the carrier components and/or any material used in the manufacture Comments

2.4.1 Synthetic Yes No N/A

2.4.2 Fermentation Yes No N/A

2.4.3 Vegetable Yes No N/A

2.4.4 Mineral Yes No N/A

2.4.5 Animal (if YES, please complete section B as well) Yes No N/A

2.4.5 Bovine (or by-products) Yes No N/A

2.4.5 Porcine (or by-products) Yes No N/A

2.4.5 Poultry (or by-products) Yes No N/A

2.4.5 Fish (or by-products) Yes No N/A

2.4.5 Human (or by-products) Yes No N/A


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2.5 Additives (if applicable) Comments

2.5.1 Additive E Numbers Yes No N/A

2.5.1 Other additives than colours and sweeteners (Dir. Yes No N/A
95/2/EC* and subsequent amendments.)

2.5.1 Purity criteria (Dir. 96/77/EC* and subsequent Yes No N/A


amendments.)

2.5.1 Other relevant purity criteria applicable Yes No N/A

2.6 Other products supplied to us:

3. Quality Standards and Certifications


3.1 Do you hold certification(s) against any recognized quality standards
by a accredited third party body e.g. ISO 9001, 14001 or 22000? If Yes Ref: No N/A
yes, please provide a copy of certificate(s).

3.2 Do you hold accreditation, certification or registration by any


regulatory agency or body? If yes, please provide a copy of Yes Ref: No N/A
documentation
3.3 Are any aspects of the process / service provided subcontracted? Yes No N/A

3.3.1 If so, please provide detail:

3.3.2 Are there Quality / Technical Agreements held with subcontractors? Yes No N/A
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4. Quality Management Documentation


Do you have procedures that document how you perform the following activities:
If ‘YES’ please provide the document reference number / identification.
In case you are certified towards ISO9001, only 4.1.2, 4.1.7, 4.1.11, 4.2.1, 4.2.2, 4.4.1, 4.4.4 and 4.5.2 are mandatory.
4.1 QUALITY SYSTEM Comment
4.1.1 Quality Policy / Manual Yes No N/A
4.1.2 Equipment & Instrument Validation / Qualification
Yes No N/A
Program
4.1.3 Internal Audit / Self-Inspection Program Yes No N/A
4.1.4 Supplier Evaluation / Qualification Program Yes No N/A
4.1.5 Does your company operate a supplier-auditing system? Yes No N/A
4.1.6 Training Program Yes No N/A
4.1.7 Change Control Yes No N/A
4.1.8 Deviation / Investigation Reporting Yes No N/A
4.1.9 Non-Conformance Reporting Yes No N/A
4.1.10 Documentation Control Yes No N/A
4.1.11 Do you have a recall system/procedure in place? Yes No N/A
4.2 PRODUCTION / OPERATIONS SYSTEM
4.2.1 Environmental Monitoring Program Yes No N/A
4.2.2 Housekeeping Program Yes No N/A
4.2.3 Gowning / Entry & Exit Procedure Yes No N/A
4.2.4 Availability of Master Production Instructions and Batch
Yes No N/A
production Records
4.2.5 Availability of Equipment Cleaning Procedures, Cleaning
Yes No N/A
Records and Cleaning Verification
4.3 PACKAGING / LABELLING SYSTEM
4.3.1 Labelling of Intermediate / Final Products Yes No N/A
4.3.2 Storage of Intermediate / Final Products Yes No N/A
4.3.3 Product / Sample Shipping Validation Program Yes No N/A
4.4 FACILITIES AND EQUIPMENT SYSTEM
4.4.1 Pest Control Program Yes No N/A
4.4.2 Preventive Maintenance Program Yes No N/A
4.4.3 Calibration Program Yes No N/A
4.4.4 Facility Cleaning / Sanitization Yes No N/A
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4.5 LABORATORY CONTROL SYSTEM Comment


4.5.1 Method Qualification for all assays used in Testing of
Yes No N/A
Samples
4.5.2 Testing Reagents and Standards Controls Policy /
Yes No N/A
Procedure
4.5.3 Sample Retention Program Yes No N/A
4.5.4 Out of Specification (OOS) / Retest Procedures Yes No N/A
4.5.5 Availability of Analytical Raw Data Documentation Yes No N/A
4.6 MATERIALS CONTROL SYSTEM
4.6.1 Materials Movement into the Facility Yes No N/A
4.6.2 Inventory Management System Yes No N/A
4.6.3 Warehouse System and Storage Yes No N/A
4.6.4 Inspection and Testing of Incoming Materials Yes No N/A
4.7 OTHER
4.7.1 Contract Review Yes No N/A
4.7.2 Supply Chain Requirements Yes No N/A
4.7.3 Product Identification / Traceability Yes No N/A

5. Regulatory Compliance and History


Has the company been subject to periodic audit by competent authorities
5.1 Yes No N/A
e.g. MHRA, FDA, ISO inspection body etc?
If ‘YES’ please provide details below for the past 2 years and attach supporting documents (e.g. ISO certificate,
5.1.1
GMP certificate, EIR cover letter)
Authority Date Result
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Regulatory Compliance
5.2 Comment
(If YES is applicable, please specify the legislation the material is compliant with)
Remark:
If YES, please specify the legislation you are compliant to

5.2.1 Mycotoxin (Regulation 1881/2006/EC and subsequent


Yes No N/A
amendments)
5.2.2 Dioxin (Regulation 1881/2006/EC and subsequent Yes No N/A
amendments)
5.2.3 Ionisation Yes No N/A
5.2.4 Pesticide Residues Yes No N/A
5.2.5 Heavy Metals Specified Yes No N/A
5.2.6 Polycyclic Aromatic Hydrocarbons (PAH) Yes No N/A
5.2.7 Polychlorinated Biphenyls (PCBs) Yes No N/A
5.2.8 Nitrate Yes No N/A
5.2.9 BSE / TSE Yes No N/A
5.2.10 Product Data Sheet Yes No N/A
5.2.11 Safety Data Sheet Yes No N/A

6. Industry History
Do you supply to any other customer in the Pharmaceutical / Health care
6.1 Yes No N/A
industry?
If ‘YES’, Please specify the approximate % of your business that this relates
6.1.1
to:
Have you been audited by any Pharmaceutical / Health care companies
6.2 Yes No N/A
within the last two years?
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7. Comments
Supplier Quality Questionnaire

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8. References - Appendices
Please, list all references and enclosures that you make to this questionnaire and specify the reference number
given to each document. Use one list for all sections of the document and extend it if needed.

Ref # Description/Name
Supplier Quality Questionnaire

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9. Sections completed
Please, tick the boxes for the sections you have completed.

Sections A – General Company Information and Quality Management Questionnaire


Sections B – BSE/BSE Risk Analysis Survey
Sections C – GMO – Vegetable Origin
Sections D – Allergen
Sections E – Extended Quality Questionnaire for Critical Material
Sections F – Packaging Material

Completion Signatures
 Confirmation that enclosed information is correct and relevant to the product(s) in scope.
 You will inform us in case of any changes to the product status

Site Operations Lead Representative:

Name (Print ):

Position:

Signature:

Date:

Head of Quality Assurance or representative; person who completed the questionnaire:

Name (Print):

Position:

Signature:

Date: